WHO Offers PIC/S, Other Regulatory Assistance To China
This article was originally published in PharmAsia News
Executive Summary
The World Health Organization has signed a "regulatory cooperation plan" with the China Food and Drug Administration intended to help the CFDA strengthen its regulatory capabilities and to reinforce existing ties between the two organizations in a wide range of areas.
Under a new cooperative plan, the World Health Organization has agreed to offer technical assistance to the China FDA to implement a comprehensive package of measures specifically aimed at improving the quality of generic medicines, creating a more science-based and efficient review and approval system, reducing drug submission backlogs and promoting transparency of operations.
The plan identifies clear benchmarks in certain areas such as inspections, where it is envisaged that the WHO would help the CFDA prepare for a decision on joining the international pharmaceutical inspection convention and co-operation scheme (PIC/S), "and eventually achieve successful ascension to PIC/S, or achieving the equivalent standard," a WHO spokesperson told PharmAsia News’s sister publication Scrip Regulatory Affairs.
The spokesperson explained that the co-operation plan was drawn up after China requested assistance to help the CFDA attain its stated objective of becoming "a sustainable functional regulatory authority" and achieving an advanced international level of regulatory capacity. The plan was formalized at the WHO's headquarters in Geneva in September this year.
The plan identifies priority work areas for cooperation, which build upon activities that are either already underway or planned for the future. It is expected that each priority work area would be further developed into a more detailed multi-year work plan, which would describe the project scope, timelines and deliverables.
"Work plans are expected to evolve from year to year based on progress made in reaching defined objectives. Priority areas of focus may also be amended from time to time. The plan will be revised at least yearly. Decisions on activities to be undertaken will be reached by mutual consensus, taking into account available resources and other work priorities," the spokesperson added.
On the duration of the regulatory cooperation plan, the WHO spokesperson said: "The vision from both sides is for a longer cooperation which clearly goes beyond [the] next biennium but the end point has not been determined…[It is expected to be in place] at least for 2-5 years."
Long History
The WHO and the CFDA have a long history of regulatory and technical cooperation across a wide range of activities, including norms and standards development, pharmacovigilance, inspections and product evaluation.
The aim of the latest initiative is to strengthen and streamline existing ties between the two agencies by moving away from ad hoc arrangements in certain technical areas towards one single comprehensive cooperation plan.
The spokesperson explained that both agencies had shown mutual interest in further strengthening their relationship. Priority work areas under the latest regulatory cooperation plan "were agreed as a result of a constructive dialogue between the two parties, and based on the positive previous experience obtained".
While the WHO-China cooperation has so far only focused on medicinal products, the latest plan also includes medical devices, especially in the area of in vitro diagnostics, where "some cooperation is already taking place".
Background
The WHO had earlier assessed China's regulatory oversight of vaccines, which ended with the WHO formally acknowledging the country's capabilities on this front. Also, the Chinese agency responsible for vaccine quality control – the National Institutes for Food and Drug Control (NIFDC) in Beijing – is a designated WHO collaboration center, which hosts one of the three WHO-prequalified quality control laboratories in the West Pacific region.
In addition to vaccines, the WHO has offered its assistance to China to assess its regulatory systems for other product streams, such as medicines, and made its assessment tool available to Chinese authorities.
Also, the WHO has recognized the Chinese Pharmacopeia for its work in developing and validating analytical methods and reference standards and promoting good pharmacopeial practices.
(This article has also been published in Scrip Regulatory Affairs
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